Diabetes Mellitus Clinical Trial
Official title:
Pioglitazone Versus Rosiglitazone in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia
Efficacy comparison of Pioglitazone, once daily (QD), to Rosiglitazone in participants with Type 2 Diabetes
At least two metabolic defects contribute to the development of type 2 diabetes mellitus:
relative insulin insufficiency and insulin resistance. The majority of patients with type 2
diabetes mellitus demonstrate some degree of insulin resistance. Even in the absence of
hyperglycemia (high blood sugar), insulin resistance is associated with a cluster of
metabolic abnormalities that increase the risk for cardiovascular disease, including
dyslipidemia (unhealthy blood fat), increased expression of inflammatory markers, activation
of pro-coagulants (pro-clotting), hemodynamic changes, and endothelial dysfunction.
The dyslipidemia associated with insulin resistance and type 2 diabetes mellitus is
characterized by elevated triglyceride levels and decreased high-density lipoprotein (good)
cholesterol levels. Although low-density lipoprotein (bad) cholesterol levels may not be
significantly elevated in patients with type 2 diabetes mellitus, an increase in the
proportion of small, dense low-density lipoprotein cholesterol particles of increased
atherogenicity (increased formation of lipid deposits in the arteries) is observed. When
compared with individuals without type 2 diabetes mellitus, the risk of cardiovascular
disease is 2- to 4-fold greater in patients with type 2 diabetes mellitus, and the
dyslipidemia of diabetes is an important contributor to the increased risk in this
population.
By targeting the insulin resistance underlying type 2 diabetes mellitus, the
thiazolidinedione class of oral antihyperglycemic medications possesses both a
glucose-lowering effect and the potential to alter lipid/lipoprotein metabolism. Two
thiazolidinediones are currently available for the treatment of type 2 diabetes mellitus:
pioglitazone hydrochloride (ACTOS, Takeda Pharmaceuticals North America, Inc, Lincolnshire,
IL) and rosiglitazone maleate (Avandia, GlaxoSmithKline, Research Triangle Park, NC).
The purpose of this study is to evaluate the triglyceride-lowering effects of pioglitazone
to rosiglitazone in patients with type 2 diabetes mellitus and dyslipidemia who are not
receiving any other glucose- or lipid-lowering therapies at the same time as the study
medications.
Individuals who participate in this study will provide written informed consent and will be
required to commit to a screening visit and approximately 7 additional visits at the study
center. Study participation is anticipated to be about 39 weeks (or approximately 8 months).
Multiple procedures will occur at each visit which may include fasting, blood collection,
physical examinations and electrocardiograms. Participants will be required to follow a
diabetic diet, self-monitor their blood glucose and maintain a study diary for the duration
of the study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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